Abutment-Free Sophono Systems Produce Comparable Study Results to Cochlear’s Baha Products, With Fewer Complications
Implantable Hearing Device Improves Children´s Hearing, Speech Understanding.
Boulder, CO (PRWEB) May 21, 2013
Children using the abutment-free implantable bone conduction hearing device from Sophono, Inc., experience audiological results comparable to the traditionally used, competitive abutment device — and with many fewer complications, according to a new study.
“The results are yet another independent verification that Sophono´s abutment-free technology performs just as well as technology with a percutaneous device — but with many fewer complications,” says Jim Kasic, president and CEO of Sophono.
Sophono is a Colorado-based medical device manufacturer. The Sophono Alpha System is the only abutment-free, implantable, bone-anchored hearing system on the market, treating those with conductive hearing loss, mixed hearing loss and single-sided deafness. Fitted to the patient´s head with the use of small, implantable magnets, the Sophono Alpha System eliminates problems associated with other bone conduction hearing systems. These include drilling a hole in the patient´s skull and installing a very noticeable screw that pokes out through the skin on the side of the head.
The article summarizing the study findings appears in the May issue of Otology & Neurotology (“Comparison Between a New Implantable Transcutaneous Bone Conductor and Percutaneous Bone-Conduction Hearing Implant”). The study, conducted in the Radboud University Nijmegen Medical Center (Nijmegan, The Netherlands) in 2012, evaluated the results of children implanted with the Sophono Alpha 1 closed skin-device and Cochlear Limited´s Baha® abutment-based device. The children, between the ages of 5 and 12, all suffered from congenital unilateral conductive hearing loss.
The study conducted a review of patient benefit at one year of use with both systems. Results showed these findings.
1. The children experienced the same improvement in hearing levels, from severe conductive loss to nearly normal hearing.
2. The children experienced the same statistical and clinical improvement in speech understanding.
3. The children with the Sophono Alpha device experienced fewer complications than the Baha device.
The only notable difference between the groups, explains Kasic, was that the study found 17 percent of those implanted with the Baha device had complications that required them to return to the operating room for additional surgery (to replace the device which had fallen out of their heads).
“Audiologists and otolaryngologists now can be even more confident that young patients can realize hearing improvement without the cosmetic and hygienic problems of an abutment,” says Kasic. Parents´ requests for the Sophono technology are becoming more frequent as well, he adds. “Thanks to Sophono´s use of magnets, Sophono Alpha users can obtain better hearing without the skin-protruding screws of the Baha device.”
Sophono, Inc. (http://www.sophono.com)
Sophono, Inc., is a medical device manufacturer specializing in abutment-free, implantable, bone conduction hearing systems. The company´s products are designed for individuals suffering from severe to profound hearing loss or impairment. The Sophono Alpha 2 System is the only abutment-free, implantable, bone-anchored hearing system available today. Treating those with conductive hearing loss, mixed hearing loss, and single-ear deafness, the FDA-cleared Alpha 2 eliminates the problematic abutment of devices by using magnets to affix external sound processors.
Sophono corporate headquarters and manufacturing operations reside in Boulder, Colo. The company maintains an office in Germany, works with more than 20 distributors, and is actively selling in more than 30 countries.
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